Sheath assembly and delivery system for manipulating implants

Abstract

The invention provides a sheath assembly for manipulating an implant and a delivery system including the same. The sheath assembly includes a handle housing, a multi-lumen tube, an actuation shaft, and an actuation shaft control mechanism. The actuating shaft control mechanism comprises a control knob and an axial limiting stopper capable of releasing limiting. The axial stopper is selectively coupled to a first position or a second position proximal to the actuation shaft. When the axial stopper is coupled to the first position, the actuating shaft is axially movable between a distal position and a first proximal position under rotation of the control knob. When the actuating shaft is located at the first proximal position and the axial limiting of the axial limiter at the first position is released, the actuating shaft can be separated from the rotation effect of the control knob and continuously move towards the proximal end in the axial direction to enable the axial limiter to be coupled to the second position. A foundation is laid for secondary use of the conveying system.

Description

Technical Field

[0001] The present invention relates to the field of interventional medical devices, and in particular to a sheath tube assembly and a delivery system for manipulating implants in a heart valve repair system. Background Art

[0002] Existing heart valve repair clips are all pre-installed, and the clips and delivery systems are assembled at the factory. One delivery system matches one clip. When multiple clips need to be implanted during surgery or the device fails, the entire system and clips need to be replaced. The delivery system or clip cannot be replaced separately. Therefore, several sets of instruments of different specifications and models need to be prepared for backup during surgery, which increases the stocking and transportation costs of the product. In addition, for related products currently on the market, during surgery, the valve clip release stage generally requires the withdrawal of a line that runs through the entire delivery system, which increases both the operation time and the risk of bleeding. Summary of the invention

[0003] To solve the above problems, the present invention provides a sheath assembly and a delivery system for manipulating an implant.

[0004] On the one hand, a sheath assembly for manipulating an implant comprises a handle housing, a multi-lumen tube, an actuating shaft and an actuating shaft control mechanism. The multi-lumen tube extends distally from the handle housing, the actuating shaft extends through the multi-lumen tube, and the actuating shaft is configured to be coupled to the implant. The actuating shaft control mechanism comprises a control knob and an axial stopper that can release the limit. The control knob is coupled to the actuating shaft, and the control knob can rotate relative to the handle housing, wherein the rotation of the control knob causes the actuating shaft to move axially relative to the handle housing and the multi-lumen tube. The axial stopper can be selectively coupled to a first position or a second position located proximal to the actuating shaft. When the axial stopper is coupled to the first position, the actuating shaft can move axially between the distal position and the first proximal position under the rotation of the control knob. When the actuating shaft is located at the first proximal position and the axial stopper is released in the first position, the actuating shaft can be separated from the rotation of the control knob and continue to move axially toward the proximal end to couple the axial stopper to the second position. When the axial limiter is coupled to the second position, the axial limiter provides axial limitation to the actuating shaft at the second position, and the actuating shaft is located at the second proximal position. The first position is located proximal to the second position. When the actuating shaft is located at the distal position, the opening angle of the implant is maximum. When the actuating shaft is at the first proximal position, the opening angle of the implant is minimum. When the actuating shaft is at the second proximal position, the actuating shaft and the implant are in a disconnected state, and the distal end of the actuating shaft is restored to a state where the implant can be reconnected.

[0005] Furthermore, the actuating shaft control mechanism also includes a push screw, which is axially movably connected to the handle housing and is axially fixed relative to the axial limiter. The push screw is threadably coupled to the control knob, so that rotation of the control knob advances or retracts the push screw in the axial direction, thereby causing axial movement of the actuating shaft.

[0006] Furthermore, the actuating shaft control mechanism further includes an axially extending cylindrical body, the proximal end of the actuating shaft is fixedly connected to the cylindrical body, the distal end of the cylindrical body extends axially into the push screw, and the cylindrical body provides a first position and a second position. When the axial limiter is coupled to the first position or the second position, the cylindrical body and the push screw are relatively fixed in the axial direction. When the axial limiter is uncoupled from the first position or the second position, the cylindrical body can move axially relative to the push screw.

[0007] Further, the axial limiter is arranged at the proximal end of the push screw, and the proximal end of the push screw is provided with a receiving groove. The axial limiter is constructed to include a push piece, a stopper and a spring piece, the stopper includes an annular plate and a first end and a second end extending from the annular plate to two radially opposite sides, the first end of the stopper is connected to the push piece, the second end of the stopper is connected to one end of the spring piece, and the other end of the spring piece is located and abutted in the receiving groove. The cylindrical body extends through the middle hole of the annular plate, and the cylindrical body is provided with a first engagement groove corresponding to the first position and a second engagement groove corresponding to the second position. When the spring piece makes the annular plate engage with the first engagement groove or the second engagement groove, the push piece is in a pop-up state, and the axial limiter is coupled to the first position or the second position. When the push piece is in a pressed state, the spring piece is compressed, the annular plate is released from the first engagement groove or the second engagement groove, and the axial limiter is released from the first position or the second position. Preferably, the cross section of the first engagement groove is configured as a non-circular structure.

[0008] Further, the actuating shaft control mechanism also includes a one-way clutch extending radially into the push screw, the one-way clutch and the push screw are relatively fixed in the axial direction, the inner end of the one-way clutch is configured to include asymmetric teeth, and the inner end of the one-way clutch can be releasably abutted against the cylindrical body. A section of the cylindrical body where the one-way clutch abuts is configured as a spline, and the spline key teeth of the abutting portion are configured as a one-way ratchet, which can be engaged with the inner end of the one-way clutch. When the inner end of the one-way clutch is engaged with the cylindrical body, the cylindrical body can rotate in a first direction to disengage the actuating shaft from the implant, and inhibit the cylindrical body from rotating in a second direction. When the inner end of the one-way clutch is disengaged from the cylindrical body, the cylindrical body can rotate in a second direction to allow the actuating shaft to be secondary connected to the implant. Wherein, the first direction is opposite to the second direction.

[0009] Specifically, the one-way clutch includes a clutch sleeve, a clutch shaft and a clutch spring. The inner end of the clutch shaft is configured to include the asymmetric teeth, the clutch spring is sleeved to the clutch shaft, one end of the clutch spring abuts against the inner wall of the push screw, and the other end of the clutch spring abuts against the inner end of the clutch shaft. The clutch sleeve and the clutch shaft are relatively fixed in the axial direction of the clutch shaft, and the clutch sleeve is rotatably connected to the outer end of the clutch shaft around the axis of the clutch shaft. A protrusion is provided on the outer periphery of the clutch sleeve, and a notch capable of receiving the protrusion is provided on the outer periphery of the push screw. When the clutch sleeve rotates and moves inwardly so that the protrusion is seated in the notch of the push screw, the inner end of the clutch shaft meshes with the cylindrical body under the action of the clutch spring, and the side wall of the notch limits the rotation of the clutch sleeve. When the clutch sleeve moves outward to disengage the protrusion from the notch of the push screw, the clutch spring is compressed, the inner end of the clutch shaft disengages from the cylindrical body, and the clutch sleeve is rotated to abut against the non-notch portion of the outer periphery of the push screw. Preferably, the one-way clutch further comprises a clutch knob, which is fixedly connected to the clutch sleeve from the outside, and an anti-slip feature is provided on the outer periphery of the clutch knob.

[0010] More specifically, the push screw is constructed to include a small diameter section and a large diameter section arranged in the axial direction. The small diameter section provides a rotation coupling path for the control knob, and the rotation of the control knob causes the push screw to move axially, thereby causing the actuating shaft to move axially relative to the handle housing and the multi-lumen tube. The large diameter section provides an installation position for the axial limiter and the one-way clutch, and the proximal end of the cylindrical body extends beyond the proximal end of the large diameter section, and the proximal end of the cylindrical body forms a radially enlarged rotary handle. Preferably, the small diameter section is provided with a stroke indicator mark in the axial direction, and the stroke indicator mark is used to indicate the opening angle of the implant.

[0011] Preferably, the cylindrical body is provided with an axially extending hollow cavity, the actuating shaft extends through the hollow cavity and the proximal end of the actuating shaft is fixed to the proximal end of the hollow cavity. The actuating shaft is provided with a reinforcing tube, which is fixedly connected to the actuating shaft and extends from the proximal end of the hollow cavity to the proximal end of the multi-lumen tube.

[0012] On the other hand, a delivery system for delivering an implant comprises a first sheath assembly and a second sheath assembly, wherein the second sheath assembly is the sheath assembly of the aforementioned aspect. The first sheath assembly has a handle and a sheath extending from the handle in an axial direction, and the sheath of the first sheath assembly has a distal end portion, and its distal end portion includes a manipulable section. The multi-lumen tube of the second sheath assembly coaxially extends through the sheath of the first sheath assembly. A relative fixing mechanism is provided between the handle of the second sheath assembly and the handle of the first sheath assembly, and the relative fixing mechanism extends distally from the handle housing of the second sheath assembly, and the relative fixing mechanism is configured to keep the distance between the handle of the first sheath assembly and the handle of the second sheath assembly fixed. Preferably, the distance between the handle of the first sheath assembly and the handle of the second sheath assembly is adjustable.

[0013] The present invention provides a conveying system with replaceable and reusable flap clips, especially a sheath assembly for manipulating implants, which can reduce the stocking and transportation costs of the equipment, and also reduce the use costs, thus bringing great benefits to patients. In addition, the modules of the conveying system are clearly divided, the operating parts of the handle are ergonomic, and the flap clip release structure is effectively integrated into the handle, so that there is no need to pull out the entire flap clip control line, which effectively shortens the operation time and lays a foundation for the secondary use of the conveying system. Specifically, the beneficial effects of the present invention include: 1) Higher surgical flexibility: The design of the replaceable flap clip allows the clip to be replaced as needed during the operation without replacing the entire conveying system, which increases the flexibility and adaptability of the operation; 2) Reduce costs and resource waste: Since there is no need to prepare a complete system for each possible situation, inventory and transportation costs can be reduced, while reducing resource waste; 3) Improve surgical efficiency: During the operation, if an instrument fails or a clip of a different specification is required, it can be quickly replaced, reducing the risk of interruption of the operation and prolonged operation time; 4) Reduce patient risks: Rapid replacement of clips can reduce operation time and reduce the risk faced by patients due to long-term surgery; 5) Easy to operate and learn: The system is easy to operate and has a short learning curve. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to more clearly illustrate the technical solutions in the embodiments of the present disclosure, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present disclosure. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0015] Figure 1 A schematic diagram of a valve repair system of the present disclosure is shown;

[0016] Figure 2 A schematic diagram of a delivery system of the present disclosure is shown;

[0017] Figure 3 A schematic diagram showing two sheath tube assemblies in the delivery system of the present disclosure and a relative fixing mechanism therebetween;

[0018] Figure 4 A schematic diagram showing a sheath assembly for controlling an actuating wire and an actuating shaft in a delivery system of the present disclosure and an implant connected thereto for controlling the actuating wire and the actuating shaft is shown;

[0019] Figure 5A A perspective schematic diagram showing a handle of a sheath assembly for connecting and manipulating an actuating wire and an actuating shaft;

[0020] Figure 5B Shows Figure 5AAn exploded schematic diagram of the handle housing of the middle handle and components connected thereto;

[0021] Fig. 6A Shows Figure 5A A portion of a handle with a portion of the handle housing and internal components removed, showing the basic arrangement of push-pull components for controlling axial movement of the actuating wire;

[0022] Figure 6B Shown Fig. 6A An exploded schematic diagram of the push-pull components, namely a pair of push seats and a pair of push buttons;

[0023] Figure 6C It is a cross-sectional schematic diagram of a pair of push buttons when both are in the first parking position, cut transversely from the center of the push buttons and looking toward the proximal end, showing the transverse connection state of the pair of push buttons and the pair of push seats when the two actuating wires are independently controlled to move axially;

[0024] Fig.6D It is a cross-sectional schematic diagram of a pair of push buttons when both are in the first parking position, cut transversely from the center of the push buttons and looking toward the proximal end, showing the transverse connection state of the pair of push buttons and the pair of push seats when the two actuating wires are synchronously controlled to move axially;

[0025] Fig. 7A and Figure 7B A three-dimensional schematic diagram and an exploded schematic diagram of the third limiting portion without the slide groove mechanism are respectively shown;

[0026] Fig. 8A Taking the second push button as an example, a longitudinal cross-sectional schematic diagram of the positional relationship between the first limit portion, the pushing seat and the stopper of the third limit portion when the push button is located at the first stop position is shown, wherein some components are removed for a clearer illustration;

[0027] Figure 8B Taking the second push button as an example, a longitudinal cross-sectional schematic diagram of the positional relationship between the second limit portion, the pushing seat and the stopper of the third limit portion when the push button is located at the second stop position is shown, wherein some components are removed for clear display;

[0028] Figure 8C and Fig.8D The three-dimensional schematic diagrams of the push slide rail viewed from the top and from the bottom are shown respectively;

[0029] Fig.9A Shows Figure 5A A portion of the handle with part of the handle housing removed, showing the basic arrangement of the sheath holder;

[0030] Fig. 9B A schematic transverse cross-sectional view of the connection between the sheath tube fixing seat and the actuating wire withdrawal assembly looking toward the distal end is shown;

[0031] Fig. 9C Shows Figure 5A A schematic transverse cross-sectional view of the actuating wire retraction assembly of the middle handle looking toward the proximal end;

[0032] Fig. 10A Shows Figure 5A A longitudinal cross-sectional view of the handle along the central axis after the actuating shaft is removed, Fig. 10B Shown Fig. 10A A local enlarged schematic diagram of M1 in FIG.

[0033] Fig. 10C An exploded schematic diagram of the sheath tube fixing seat and the first set of sealing structures is shown;

[0034] Fig. 10D A schematic top view of a handle of a sheath assembly for connecting and manipulating an actuating wire and an actuating shaft is shown when the actuating shaft is located at a first proximal position;

[0035] Fig.11A Shows Figure 5A An exploded schematic diagram of a portion of the components connecting the proximal end of the middle handle and the axial stopper;

[0036] Fig. 11B and Fig. 11C The schematic transverse cross-sectional views looking toward the proximal end when the axial limiter provides axial limit to the actuating shaft in the first position and releases the axial limit are respectively shown;

[0037] Fig.11D and Fig.11E The schematic transverse cross-sectional views looking toward the proximal end when the axial limiter provides axial limit to the actuating shaft at the second position and releases the axial limit are respectively shown;

[0038] Fig. 12A and Fig. 12B The schematic cross-sectional views looking toward the proximal end are respectively shown when the one-way clutch restricts the one-way rotation of the cylindrical body and releases the one-way rotation;

[0039] Fig. 12C Shown Figure 5A An exploded schematic diagram of a portion of the components connecting the proximal end of the middle handle to the one-way clutch. DETAILED DESCRIPTION

[0040] The following will be combined with the drawings in the embodiments of the present disclosure to clearly and completely describe the technical solutions in the embodiments of the present disclosure. Obviously, the described embodiments are only part of the embodiments of the present disclosure, not all of the embodiments. Based on the embodiments in the present disclosure, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present disclosure.

[0041] In describing the present invention, "proximal" or "proximal end" refers to the direction toward the end of the device manipulated by the user outside the patient's body, and "distal" or "distal end" refers to the direction toward the working end of the device positioned at the treatment site and away from the user. When one or more components are described as connected, linked, fixed, connected, attached or otherwise interconnected, such interconnection may be a direct interconnection between components, or may be an indirect interconnection, such as interconnection by using one or more intermediate components. Unless otherwise expressly defined, the terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions. The term "radial" refers to a direction perpendicular to the axis and pointing along a radius starting from the center of the object (with the axis at the center). The term "longitudinal section" refers to a section along the length or axial direction of the device, and the term "transverse section" refers to a section along the width or radial direction of the device. The term "inside" refers to a direction in the transverse / radial direction close to the central axis of the device. The term "outside" refers to a direction in the transverse / radial direction away from the central axis of the device.

[0042] Directional and other relative references (e.g., up, down) may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. When dealing with relative relationships, particularly with respect to the examples shown, such terms are used, where applicable, to provide some clarity of description. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, the "upper" portion of an object may become the "lower" portion simply by flipping the object over. Nonetheless, it is still the same portion and the object remains unchanged.

[0043] The present invention provides an interventional device 10 (eg, a valve repair system) for grasping, approximating, and clamping tissue, such as a valve leaflet, to treat heart valve regurgitation, particularly mitral valve regurgitation, with reference to Figure 1 The interventional device 10 includes an implant 100 and a delivery system 20, wherein the delivery system 20 may include multiple sheath assemblies. The delivery system 20 is configured to make it easier to move the implant between its various configurations and / or implant the implant into a native heart valve.

[0044] In some embodiments, such as Figure 2 In the illustrated example, the delivery system 20 includes a sheath assembly 250, a sheath assembly 260, and a sheath assembly 270. However, in some embodiments, the delivery system 20 may include fewer or more sheath assemblies than shown in the figure. In some embodiments, the sheath assembly 270 is configured as a guide sheath assembly, the sheath assembly 260 is configured as a steerable sheath assembly, and the sheath assembly 250 is configured as an implant steering sheath assembly.

[0045] In some embodiments, sheath assembly 260 extends coaxially through sheath assembly 270, and sheath assembly 250 extends coaxially through sheath assembly 260 and sheath assembly 270. Implant 100 can be releasably coupled to a distal portion of sheath assembly 250.

[0046] like Figure 2 As shown in , each of the sheath assemblies includes a sheath / shaft / sheath 59, 69, 79 extending from a handle 51, 61, 71, respectively. The handles 51, 61, 71 are located at the proximal end of each of the corresponding sheath / shaft / sheaths and include one or more control members to enable a user to manipulate the sheath assembly (e.g., bend or rotate the sheath / shaft / sheath of the sheath assembly) or control components coupled to the corresponding sheath assembly (e.g., an actuation shaft and an actuation wire extending through the sheath / shaft / sheath of the sheath assembly).

[0047] Sheath assembly 270 and sheath assembly 260 can be used, for example, to approach an implantation site (e.g., the native mitral valve region of the heart) and / or to position sheath assembly 250 at an implantation site. Thus, in some embodiments, sheath assembly 270 and sheath assembly 260 are both configured to be maneuverable (adjustable).

[0048] The sheath assembly 250 includes a handle 51, an actuating shaft 220, an actuating wire 230, and a sheath 59, wherein the sheath 59 is configured as a multi-lumen tube, through which the actuating shaft 220 and the actuating wire 230 are releasably connected to the implant 100 from the distal side, and the proximal ends of the actuating shaft 220 and the actuating wire 230 are connected to a control member in the handle 51. The manipulation of the implant 100 by the actuating shaft 220 and the actuating wire 230 of the sheath assembly 250 can be operated in the same manner as shown and described in the Chinese patent application publication with publication number CN118161307A, the entire contents of which are incorporated herein by reference.

[0049] refer to Figure 3According to the delivery system 20 provided by the present invention, a relative fixing mechanism 544 is provided between the handle 51 of the sheath assembly 250 and the handle 61 of the sheath assembly 260. When the operator takes out the delivery system 20 from the package and places it on the stabilizer, or withdraws the delivery system 20 for secondary loading and then places it on the stabilizer, since the sheath 59 itself is relatively soft, the operator is prone to damage the sheath 59 when grabbing one of the handles. Adding the relative fixing mechanism 544 can protect the sheath 59. For example, the relative fixing mechanism 544 is constructed to include a sleeve 544a, a sleeve 544b and a fastening bolt 544c, wherein the sleeve 544a is relatively fixedly connected to the distal end of the handle 51, and the sleeve 544b is relatively fixedly connected to the proximal end of the handle 61; the distal end of the sleeve 544a and the proximal end of the sleeve 544b are mutually sleeved, wherein a threaded hole is provided on the wall of the sleeve sleeved outside, and the fastening bolt 544c is screwed into the threaded hole to fix the two sleeves, so that the axial distance between the handle 51 and the handle 61 is kept fixed. Preferably, the axial distance between the handle 51 and the handle 61 is adjustable, specifically, the distance between the handle 51 and the handle 61 can be adjusted by adjusting the depth of the two sleeves nesting each other, that is, adjusting the distance between the distal end of the sleeve 544a and the proximal end of the sleeve 544b. When the distance between the distal end of the sleeve 544a and the proximal end of the sleeve 544b decreases, the distance between the handle 51 and the handle 61 increases; when the distance between the distal end of the sleeve 544a and the proximal end of the sleeve 544b increases, the distance between the handle 51 and the handle 61 decreases. By adjusting the distance between the sleeve 544a and the sleeve 544b, the sheath assembly 250 can be axially moved relative to the sheath assembly 260, thereby adjusting the relative position of the implant in the heart.

[0050] More specifically, the sleeve 544a is configured as an outer sleeve, the sleeve 544b is configured as an inner sleeve, and the sheath 59 extends from the handle 51 through the sleeve 544b and then coaxially extends through the sheath assemblies 260 and 270. The proximal end of the sleeve 544a is provided with an internal thread, and the sleeve 544a and the distal end of the handle 51 are fixedly connected by a threaded manner; a threaded hole is provided on the wall of the distal end of the sleeve 544a, and the fastening bolt 544c passes through the threaded hole at the distal end of the sleeve 544a to fix the two sleeves. A fixing plate is provided at the proximal end of the handle 61, and the distal end of the sleeve 544b is fixedly connected to the fixing plate at the proximal end of the handle 61 by a threaded manner. The proximal end of the sleeve 544b is provided with a flange structure, which matches the inner cavity size of the sleeve 544a, and the flange structure cooperates with the distal feature of the sleeve 544a to make the sleeve 544b and the sleeve 544a inseparable, thereby limiting the maximum relative movement distance between the handle 51 and the handle 61, preventing the operator from damaging the sheath 59 due to misoperation during use.

[0051] Figure 4A schematic diagram of an implant manipulation sheath assembly 250 is shown, and reference is made to Figure 1 , the actuating wire 230 is configured as a pair, and the sheath 59 (multi-lumen tube) has at least three longitudinally extending lumens, one of which is used to arrange the actuating shaft 220, and the other two lumens are used to arrange one actuating wire 230 respectively. Each actuating wire 230 is connected to an actuating wire control mechanism 530 positioned on the handle 51, and the actuating shaft 220 is connected to the actuating shaft control mechanism 520 positioned on the handle 51. The actuating shaft 220 can extend distally from the actuating shaft control mechanism 520, pass through the handle 51, pass through the sheath 59, and be connected to the implant 100 from the distal end. The actuating shaft 220 can move axially and / or rotationally relative to the sheath 59 and the handle 51. The actuating wire 230 can extend distally from the actuating wire control mechanism 530, pass through the handle 51, the sheath 59, and be connected to the buckle 160 of the implant 100 from the distal end. The actuation wire 230 can move axially relative to the handle 51 and the sheath 59 , and can also move axially relative to the actuation shaft 220 .

[0052] According to the implant manipulation sheath assembly 250 provided by the present invention, the distal end of each actuating wire 230 is arranged at the distal side close to the sheath 59, and the proximal end of each actuating wire 230 is arranged at the proximal side close to the sheath 59. When the implant 100 is manipulated, each actuating wire 230 drives the buckle 160 of the implant 100 to move in a single-wire motion mode. After the implant 100 is implanted and the actuating shaft 220 and the actuating wire 230 are separated, the actuating shaft 220 and the actuating wire 230 can be maintained at the distal end of the sheath 59 for reuse, thereby completing the secondary connection to a new implant. It should be noted that the actuating wire in the prior art is generally in a "U"-shaped structure, which has a first section extending far from the proximal end of the conveying system and a second section returning from the distal end of the conveying system to the proximal end along the axial length direction of the conveying system, and the distal end and proximal end of the actuating wire are both located at the proximal side of the conveying system. The actuating wire 230 of the present disclosure is of a "monofilament" structure, which means that one end of the actuating wire 230 is at the proximal end of the delivery system 20 and the other end is at the distal end of the delivery system 20, but does not mean that the actuating wire 230 itself is a single strand or a single wire.

[0053] refer to Figure 5A and Figure 5B The handle 51 includes a handle housing 511, which can be constructed of an upper housing 511a and a lower housing 511b that can be interlocked, and the interior of the handle housing 511 can provide accommodation space for multiple components. The handle housing 511 generally includes two sections in the longitudinal direction, the proximal end of the actuating wire 230 and the actuating wire control mechanism 530 are arranged and attached to the distal section of the handle housing 511, and the proximal end of the actuating shaft 220 and the actuating shaft control mechanism 520 are arranged and attached to the proximal section of the handle housing 511.

[0054] According to the sheath assembly 250 provided by the present invention, the actuator wire 230 of the "monofilament" structure includes a single-line main body segment and a return segment adjacent to the proximal side of the main body segment, the main body segment extends through the sheath 59 and the return segment does not pass through the sheath 59, and the return segment is connected to the push-pull component (described in detail below) of the actuator wire control mechanism 530. The push-pull component of the actuator wire control mechanism 530 can move axially relative to the handle housing 511, and the axial movement of the push-pull component can enable the buckle 160 of the implant 100 to move between an open configuration and a closed configuration. Specifically, the axial movement of the push-pull component can drive the actuator wire 230 to move axially, thereby driving the buckle 160 connected to the actuator wire 230 to move. It should be noted that the prerequisite for controlling the actuator wire 230 by the actuator wire control mechanism 530 in the present invention is that the implant 100 is in an open state (the clip 150 is in an open state, refer to Figure 1 ).

[0055] According to one or more embodiments provided by the present invention, when the push-pull component moves axially, the distance that the actuator wire 230 retreats or advances is greater than the distance that the push-pull component moves axially. For example, the return section of the actuator wire 230 includes only one return, and the distance that the actuator wire 230 retreats or advances axially is twice the distance that the push-pull component moves axially. The actuator wire of the U-shaped loop needs to travel the entire length of the conveying system to completely release the buckle plate, while the actuator wire of the "single wire" loop provided by the present invention only needs to travel twice the distance from the buckle plate to the distal end of the sheath 59 to completely release the buckle plate, and does not need to travel the entire length of the conveying system. The movement distance of the actuator wire withdrawal can be effectively shortened, thereby shortening the withdrawal time of the actuator wire, and further shortening the operation time. In addition, the actuator wire does not need to be completely withdrawn from the conveying system, which can achieve the purpose of secondary loading of the implant. The actuator wire control mechanism 530 can shorten the movement distance of the actuator wire in the handle section, thereby shortening the overall size of the handle.

[0056] Optionally, the push-pull component in the actuator wire control mechanism 530 is configured to manipulate the two actuator wires 230 only simultaneously (in linkage); optionally, the push-pull component in the actuator wire control mechanism 530 is configured to manipulate the two actuator wires 230 only independently; preferably, the push-pull component in the actuator wire control mechanism 530 is configured to manipulate the two actuator wires 230 independently and simultaneously (in linkage). According to one or more embodiments provided by the present invention, the push-pull component in the actuator wire control mechanism 530 is configured to manipulate at least the two actuator wires 230 independently.

[0057] In some embodiments, a push slide 512 is provided in the handle 51, and the push slide 512 is axially extended and arranged inside the handle housing 511 and fixed relative to the handle housing 511. The actuating wire control mechanism 530 is configured to include an axially movable push-pull component, at least a portion of which can move axially along the push slide 512, the return section of the actuating wire 230 is attached to the push-pull component, and the actuating wire 230 moves with the axial movement of the push-pull component, so that the actuating wire 230 is tensioned or relaxed. Optionally, the push-pull component is configured as a split type, and the push-pull component includes an active member (such as the second push button 532b described below) and a driven member (such as the second push seat 531b described below). Optionally, the push-pull component is configured as an integral type, and the push-pull component only includes an active member (such as the first push button 532a described below and the first push seat 531a constituted as a whole).

[0058] In one embodiment, the push-pull component includes a push seat and a push button. The push button is connected to the push seat, the actuating wire 230 is coupled to the push seat, and the push button is configured to move axially relative to the push slide rail 512 to drive the push seat to move axially, and the axial movement of the push seat drives the actuating wire 230 to move axially.

[0059] refer to Fig. 6A and Figure 6B The push seats are configured as a pair, both of which extend in the axial direction, one of which is provided with a first connection portion 533, and the other is provided with a second connection portion 534. After the proximal end of one actuating wire 230 is attached to the first connection portion 533, it is folded back to the distal end and fixed relative to the handle housing 511, and after the proximal end of the other actuating wire 230 is attached to the second connection portion 534, it is folded back to the distal end and fixed relative to the handle housing 511. For example, the proximal end of the actuating wire can be fixed to the handle housing 511 by knotting, gluing, screwing or riveting.

[0060] Specifically, the first connection portion 533 and the second connection portion 534 can be configured as a cavity, hole, groove, ring, loop, hook or other structure, which can prevent the actuating wire 230 from being disconnected from the push seat, and can reduce the friction resistance at the position where the push seat contacts the return section of the actuating wire 230 when the push seat moves axially. The first connection portion 533 and the second connection portion 534 can be respectively arranged at the distal end, proximal end or other suitable positions of the two push seats. Preferably, the first connection portion 533 and the second connection portion 534 can be respectively arranged at the distal end of the two push seats, and the stroke of the actuating wire needs to be sufficient to enable the two buckles to move and open 360°.

[0061] In some embodiments, the push button is configured as one, and one push button can be switchably connected to any one of the push seats, and one push button can control the axial movement of any one of the push seats or both of the push seats at the same time. In other embodiments, the push button is configured as a pair, and the two push buttons can be connected to form a whole; when the two push buttons are not connected, each push button controls the axial movement of one push seat; when the two push buttons are connected, any one push button can control the axial movement of both push seats at the same time.

[0062] Optionally, the push button is configured as one, and one push button can selectively manipulate one or two push seats. For example, the push button is provided with a first push seat coupling portion and a second push seat coupling portion arranged in a radial direction, and the first push seat coupling portion and the second push seat coupling portion can both selectively move radially outward to couple with the corresponding push seat, so that the push button manipulates one or two push seats. The push seat coupling portion can be radially moved by pressing, so that the push seat coupling portion is coupled or decoupled with the push seat.

[0063] Optionally, the push button is constructed as a pair, and the two push buttons are respectively connected to a push seat. Fig. 6A and Figure 6B For ease of description, a pair of push buttons are defined as a first push button 532a and a second push button 532b, a pair of push seats are defined as a first push seat 531a and a second push seat 531b, and a pair of actuating wires 230 are defined as a first actuating wire 230a and a second actuating wire 230b. The first push button 532a is configured to be axially movable relative to the push slide 512, thereby driving the first push seat 531a to move axially, and the axial movement of the first push seat 531a causes the first actuating wire 230a connected thereto to move axially. The second push button 532b is configured to be axially movable relative to the push slide 512, thereby driving the second push seat 531b to move axially, and the axial movement of the second push seat 531b causes the second actuating wire 230b connected thereto to move axially. Preferably, the push button has a gripping portion 538, and the gripping portion 538 protrudes outside the handle housing 511, which is convenient for user operation.

[0064] In some embodiments, reference Figure 6BThe first push button 532a and the first push seat 531a are constructed as an integrated structure, and the gripping portion 538 of the first push button 532a is formed on the outer side of the proximal end of the first push seat 531a, and the proximal end of the first push seat 531a is configured to include a radially extending engagement groove 535a. The second push button 532b and the second push seat 531b are constructed as a split structure, and the proximal end of the second push seat 531b is configured to include a radially extending engagement hole 535b, and a linkage shaft 535c is provided in the engagement hole 535b, and the second push button 532b can be selectively coupled to the second push seat 531b and the first push seat 531a via the linkage shaft 535c. Specifically, the second push button 532b is provided with a driving shaft 535d extending radially from the grip portion 538 to the inside of the handle housing 511, the driving shaft 535d is provided with an external thread, the linkage shaft 535c is provided with an internal thread, the driving shaft 535d is rotatably inserted into the linkage shaft 535c, and the second push button 532b is rotated to drive the linkage shaft 535c to move along the axial direction of the driving shaft 535d. The driving shaft 535d of the second push button 532 is restricted from radial movement by the handle housing 511 when rotating, and the engaging hole 535b is configured to radially receive the linkage shaft 535c while restricting the linkage shaft 535d from rotating relative to the second push seat 531b. When the first push button 532a and the second push button 532b are axially aligned and radially aligned, the second push button 532b can rotate in the first direction to drive the linkage shaft 535c to translate radially, and at least a portion of the linkage shaft 535c enters the engagement groove 535a so that the first push seat 531a and the second push seat 531b are relatively fixedly connected together to form a whole. When the first push seat 531a and the second push seat 531b are connected together to form a whole, refer to Fig.6D The axial movement of any one of the push buttons can drive the two push seats 531 to move synchronously (linked), thereby driving the two actuating wires 230 to synchronously control the opening or closing of the two buckle plates 160 on the implant 100. Further, the second push button 532b can rotate along the second direction to drive the linkage shaft 535c to disengage from the engagement groove 535a, so that the first push seat 531a and the second push seat 531b can be restored to independence, so that the two actuating wires 230 can independently control the opening or closing of the two buckle plates 160 on the implant 100, refer to Figure 6C For example, the first direction is the counterclockwise direction viewed from the second push button 532b to the first push button 532a, and the second direction is the clockwise direction viewed from the second push button 532b to the first push button 532a.

[0065] Further, refer to Figure 5AEach push button has a first stop position and a second stop position. The first stop position corresponds to the axial movement of the actuating wire 230 so that the buckle plate 160 moves to a position away from the mating element 120 in an open configuration, and the second stop position corresponds to the axial movement of the actuating wire 230 so that the buckle plate 160 moves to a position close to the mating element 120 in a closed configuration (such as Figure 1 Specifically, a first limiting portion is arranged at the far side of the push slide rail 512, and the first stop position of the push knob is at least limited by the first limiting portion; a second limiting portion is arranged at the near side of the push slide rail 512, and the second stop position of the push knob is at least limited by the second limiting portion.

[0066] In some embodiments, corresponding to the axial travel of the push button defined between the first stop position and the second stop position, the first stop portion and the second stop portion can be provided by design features on the handle housing 511. Specifically, the side wall of the handle housing 511 is provided with side features suitable for the axial movement and stop of the grip portion 538, for example, Figure 5A As shown, an open slot 511c is provided on the side of the handle housing 511 for the push button to move axially, and the push button extends through the open slot 511c to be connected to the push seat, and a part of the handle housing 511 is configured as a flat surface along the length direction of the open slot 511c to match the fitting surface of the grip portion 538, so that the push button can move more smoothly. The width of the open slot 511c is configured to be larger than the diameter of the coupling shaft between the grip portion 538 and the push seat but smaller than the lateral dimension of the grip portion 538 itself, and the first limiting portion 513 and the second limiting portion 514 are provided at both ends of the length direction of the open slot 511c.

[0067] In some embodiments, corresponding to the axial travel of the push button defined between the first stop position and the second stop position, the first limit portion and the second limit portion may be provided by components within the handle housing 511. Fig. 6A The push rail 512 provided according to the present invention is generally constructed in the shape of a flat plate, and the push button and the push seat move axially along the bottom surface of the push rail 512. Optionally, a protrusion can be extended downward from the bottom surface of the distal end and the proximal end of the push rail 512, respectively, and the protrusion can limit the axial movement of either the push button or the push seat, and the protrusions at the distal and proximal ends provide a first limit portion and a second limit portion. Optionally, a component similar to a baffle can be added to the distal end and the proximal end of the push rail 512, respectively, and the baffle can limit the axial movement of either the push button or the push seat, and the baffles at the distal and proximal ends provide a first limit portion and a second limit portion.

[0068] In some embodiments, corresponding to the axial stroke of the push button defined between the first stop position and the second stop position, the first limit portion and the second limit portion may also be provided by the design features of the handle housing 511 itself and the components inside the handle housing 511; or, one of the first limit portion and the second limit portion is provided by the design features of the handle housing 511 itself, and the other is provided by the components inside the handle housing 511. The specific implementation is similar to the aforementioned implementation, and will not be repeated.

[0069] Furthermore, a third limiting portion that can release the limiting effect is arranged at the axial position between the first limiting portion and the second limiting portion. When the push button is located at the first stop position, the third limiting portion is limited to limit the push button from moving toward the proximal side, so that the push button can be prevented from being misoperated and changing the state of the buckle 160 that has been adjusted to the open configuration. When the push button is located at the second stop position, the third limiting portion is limited to limit the push button from moving toward the distal side, so that the push button can be prevented from being driven to the distal side by the tensioned actuating wire 230 and changing the state of the buckle 160 that has been adjusted to the closed configuration. When the third limiting portion is released from the limiting effect, the push button can move from the first stop position to the second stop position or from the second stop position to the first stop position.

[0070] In some embodiments, reference Figure 5A , Figure 5B , Fig. 7A and Figure 7B , the third limiting portion 515 is configured as a push-type spring self-locking structure, including a button 53, a rotating disk 582, a slide mechanism 581, a first spring 583a, a telescopic rod 561 and a stop block 562. The slide mechanism 581 is fixed relative to the upper shell 511a and extends along the pressing direction of the button 53. Optionally, the slide mechanism 581 is integrally formed with the upper shell 511a. The button 53 and the rotating disk 582 are arranged along the pressing direction and are both coupled to the slide mechanism 581, and the side of the button 53 away from the rotating disk 582 protrudes from the slide mechanism 581 to receive the pressing. One end of the first spring 583a abuts against the rotating disk 582, and the other end of the first spring 583a abuts against the push slide rail 512. One end of the telescopic rod 561 is connected to the rotating disk 582, and the other end of the telescopic rod 561 is connected to the stop block 562. Optionally, the telescopic rod 561 and the stop block 562 are integrally formed.

[0071] Preferably, the third position-limiting portion 515 further includes a stopper 586a and a second spring 583b; a slot 586b is provided at the upper side end of the telescopic rod 561, and the stopper 586a is placed in the slot 586b and abuts against the upper surface of the rotating disk 582. The upper side end of the telescopic rod 561 is connected to the rotating disk 582 through the stopper 586a. The first spring 583a abuts between the lower surface of the rotating disk 582 and the upper surface of the push slide rail 512. The second spring 583b abuts against the rotating disk 582 and the telescopic rod 561, and the second spring 583b cooperates with the stopper 586a to connect the rotating disk 582 and the telescopic rod 561 to form a whole. The provision of the stopper 586a and the second spring 583b can facilitate the installation of the third position-limiting portion 515.

[0072] The button 53 is provided with a first tooth 584 for pushing the rotating disk 582, the rotating disk 582 is provided with a second tooth 585, and the slide mechanism 581 is provided with a circumferentially alternating long locking groove and short locking groove. Pressing the button can make the rotating disk 582 alternately coupled with the long locking groove and the short locking groove. Correspondingly, when the second tooth 585 of the rotating disk 582 is engaged in the short locking groove, the button 53 is in a pressed state; when the second tooth 585 of the rotating disk 582 is engaged in the long locking groove, the button 53 is in a pop-up state.

[0073] Pressing the button 53 can move the stopper 562 of the third limiting portion 515 in the pressing direction, so that the stopper 562 limits or releases the limit on the axial movement of the push-pull component. Specifically, when the button 53 is in the pressed state, the telescopic rod 561 extends in the pressing direction of the button 53, and the stopper 562 is driven by the telescopic rod 561 to the travel route of the push-pull component (push button and / or push seat), and the stopper 562 blocks the axial movement of the push-pull component. Pressing the button 53 again puts the button 53 in the pop-up state, and the telescopic rod 561 retracts in the pop-up direction of the button 53, and the stopper 562 is driven by the telescopic rod 561 to leave the travel route of the push-pull component (push button and / or push seat), and the stopper 562 does not block the axial movement of the push-pull component.

[0074] Specifically, for the construction mode of a pair of push seats and a pair of push buttons, the stopper 562 is constructed to include a pair of axially extending blocks 562a and 562b, and the block 562a and the block 562b are connected by a crossbeam 562c, so that the stopper 562 forms an I-shaped component as a whole. The telescopic rod 561 is specifically connected to the crossbeam 562c of the stopper 562, the block 562a is used to limit the position of the first push button 532a and / or the first push seat 531a, and the block 562b is used to limit the position of the second push button 532b and / or the second push seat 531b. The axial length of the blocks 562a and 562b needs to meet the following requirements: the distal ends of the blocks 562a and 562b extend to the axial position that can limit the push button to be stable in the first stop position, and the proximal ends of the blocks 562a and 562b extend to the axial position that can limit the push button to be stable in the second stop position.

[0075] More specifically, refer to Figure 6B The push seat includes a large end portion 537a at the proximal end and an axial length portion 537b extending from the large end portion to the distal end. The large end portion 537a has a distal side surface 537c and a proximal side surface 537d arranged opposite to each other, and the lateral dimension of the distal side surface 537c is greater than the lateral dimension of the axial length portion 537b. Fig. 8A When the second push button 532b is located at the first stop position and the third limiting portion 515 is limited, at least a portion of the proximal side surface 537d is blocked by the distal end of the stopper 562b; Figure 8B When the second push button 532b is located at the second parking position and the third limiting portion 515 is limited, at least a portion of the distal surface 537c is blocked by the proximal end of the stopper 562b.

[0076] More specifically, refer to Figure 8C The push rail 512 is constructed as a flat plate. The middle of the push rail 512 is provided with a receiving space 557 suitable for placing the stopper 562. The position corresponding to the stoppers 562a and 562b in the receiving space 557 is constructed to be a vertically through structure. When the telescopic rod 561 extends in the direction of pressing the button 53, the stoppers 562a and 562b can move downward from the receiving space 557 until the lower surface of the stoppers 562a and 562b passes over the lower surface of the push rail 512, thereby forming an obstacle on the axial travel path of the push button and / or the push seat (refer to Fig. 8A and Figure 8B). When the telescopic rod 561 is retracted toward the pop-up direction of the button 53, the blocks 562a and 562b can move upward from the accommodating space 557 to make the lower surface of the blocks 562a and 562b pass over the top of the large end 537a, so as not to constitute an obstacle on the travel path of the push button and / or the push seat. The button 53 of the third limiting portion 515 is attached to the outer wall of the upper shell 511a, and the telescopic rod 561 extends from the button 53 to the accommodating space 557 through the upper shell 511a. Furthermore, the accommodating space 557 is also provided with a mating feature 559 on the non-button side that is mated with the push-type spring self-locking structure, such as a spring mating feature, a telescopic rod mating feature, etc.

[0077] In some embodiments, the large end portion 537a is configured as a square body, and the upper surface of the square body can smoothly move axially along the bottom surface of the flat push slide rail 512. To cooperate with the axial movement of the large end portion 537a of the square body, preferably, refer to Fig.8D Corresponding to the axial stroke of the push button defined between the first stop position and the second stop position, a longitudinally extending partition 556 is provided at the bottom of the push slide rail 512, and the partition 556 forms two slideways 558a and 558b at the bottom of the push slide rail 512. Figure 6C In the sliding space of the large end 537a, the outer wall of the partition 556 and the inner wall of the handle housing 511 are both configured as a plane structure suitable for translation of the cubic wall surface. In addition, the proximal and distal ends of the push slide rail 512 and the partition 556 are provided with structural features suitable for installing and arranging the actuating shaft 220 and the reinforcing tube.

[0078] refer to 9A to 9C , the handle 51 is also provided with a sheath fixing seat 516, which is axially extended and arranged inside the handle housing 511 and fixed relative to the handle housing 511, and the proximal end of the sheath 59 is fixedly connected to the distal end of the sheath fixing seat 516. More specifically, the sheath fixing seat 516 is located at the distal end of the push slide 512, and the sheath fixing seat 516 is fixed relative to the push slide 512. The sheath fixing seat 516 is configured to have at least a longitudinally extending inner cavity 517, and the inner cavity 517 of the sheath fixing seat 516 provides a corresponding stroke of activity space and accommodation space for a section of the proximal end of the actuating wire 230 that can be driven by the push-pull component to move axially, that is, provides a corresponding stroke of activity space and accommodation space for the part of the push-pull component coupled to the actuating wire 230. In addition, the inner cavity 517 of the sheath fixing seat 516 also provides a channel for the actuating shaft 220 to extend through.

[0079] In a specific embodiment, the inner cavity 517 of the sheath fixing seat 516 includes a first sub-cavity 517a, a second sub-cavity 517b and a transition cavity 517c therebetween, and the transition cavity 517c connects the first sub-cavity 517a and the second sub-cavity 517b from the upper side. A longitudinally extending spacer 517d is provided between the first sub-cavity 517a and the second sub-cavity 517b, and the spacer 517d separates the first sub-cavity 517a and the second sub-cavity 517b from the lateral direction. The first sub-cavity 517a can provide a corresponding movement space and a containing space for the first pushing seat 521a, and the second sub-cavity 517b can provide a corresponding movement space and a containing space for the second pushing seat 521b, and the actuating shaft 220 in the handle 51 extends into the sheath 59 via the transition cavity 517c. The proximal end of the first actuating wire 230a extends in the first sub-cavity 517a, is connected to the first connecting portion 533, and is bent back in the distal direction to be fixed to one lateral side of the handle housing 511. The proximal end of the second actuating wire 230b extends in the second sub-cavity 517b, is connected to the second connecting portion 534, and is bent back in the distal direction to be fixed to the other lateral side of the handle housing 511.

[0080] More specifically, when the push button is in the first stop position, Fig. 8A , Fig.9A , Fig. 9B and Fig. 10A , most of the shaft length 537b (towards the distal end) is located in the inner cavity 517, and the large end 537a is located in the space defined by the push slide rail 512 and the lower shell 511b. Figure 8B Only the distal end of the axial length portion 537b is located in the inner cavity 517, and most of the axial length portion 537b (the proximal side) and the large end portion 537a are located in the space defined by the pushing slide rail 512 and the lower shell 511b.

[0081] Further, according to the sheath assembly 250 provided by the present invention, the proximal end of the actuating wire 230 is releasably fixed to the handle housing 511. Corresponding to the fixing positions of the proximal ends of the pair of actuating wires 230 on the lateral sides of the handle housing 511, the handle 51 also provides a pair of actuating wire retraction assemblies. Figure 5A , Fig. 6A and Fig. 9C, the first actuating wire retraction assembly 518a is fixed to one lateral side of the handle housing 511, the proximal end of the first actuating wire 230a (the outer end of the return section) is connected to the first actuating wire retraction assembly 518a, and the first actuating wire retraction assembly 518a is configured to pull the proximal end of the first actuating wire 230a outwardly away from the handle housing 511. The second actuating wire retraction assembly 518b is fixed to the other lateral side of the handle housing 511, the proximal end of the second actuating wire 230b (the outer end of the return section) is connected to the second actuating wire retraction assembly 518b, and the second actuating wire retraction assembly 518b is configured to pull the proximal end of the second actuating wire 230b outwardly away from the handle housing 511. Wherein, when the proximal end of the first actuating wire 230a or the proximal end of the second actuating wire 230b is pulled away from the handle housing 511, the push button coupled to the corresponding actuating wire is located at the second parking position. For example, when the two actuating wires 230 are independently controlled to move axially, the proximal end of the first actuating wire 230a is pulled away from the handle housing 511 when the first push button 532a is located at the second stop position, and the proximal end of the second actuating wire 230b is pulled away from the handle housing 511 when the second push button 532b is located at the second stop position. After the implant 100 is in the closed configuration, the distal end of the actuating wire 230 can be disconnected from the buckle 160 by pulling the proximal end of the actuating wire 230 away from the handle housing 511, thereby disconnecting from the implant 100 and completing the implantation operation. Since the distal end of the actuating wire 230 is provided with a limiting feature that cooperates with the distal end of the sheath 59, the distance that the proximal end of the actuating wire 230 is pulled away from the handle housing 511 is limited, thereby ensuring that the distal end of the actuating wire 230 is limited to the distal side of the sheath 59 so as to be connected to the buckle 160 again when the implant is loaded for the second time.

[0082] refer to Fig. 9CEach actuating wire retraction assembly includes a retraction fixing seat 563, a sealing end cover 564, a retraction rod 565 and a retraction rod cap 566. The retraction fixing seat 563 extends in the transverse direction, one end of the retraction fixing seat 563 is located on the inner side of the handle housing 511 and is coupled to the sheath fixing seat 516, the other end of the retraction fixing seat 563 is located on the outer side of the handle housing 511, the sealing end cover 564 is connected to the retraction fixing seat 563 from the outer side of the handle housing 511, and the retraction rod cap 566 is detachably connected to the sealing end cover 564. Specifically, the retraction fixing seat 563 and the sheath fixing seat 516 can be sealed and connected by threaded connection, glue bonding, ultrasonic welding or integrated molding. The withdrawal fixing seat 563 is provided with an inner cavity extending in the transverse direction of the handle 51, one end of the withdrawal rod 565 extends into the inner cavity of the withdrawal fixing seat 563, and the other end of the withdrawal rod 565 extends to the outer side of the sealing end cover 564 and is fixedly connected to the withdrawal rod cap 566. For example, the withdrawal rod 565 and the withdrawal rod cap 566 are fixedly connected by means of clamping, gluing or ultrasonic welding. The proximal end of the actuating wire 230 is turned back to the withdrawal fixing seat 563 distally, passes through the inner cavity of the withdrawal fixing seat 563 and is fixedly connected to the withdrawal rod 565. The withdrawal fixing seat 563 and the sealing end cover 564 are fixed relative to the handle housing 511. When the withdrawal rod cap 566 is disconnected from the sealing end cover 564, the withdrawal rod 565 can be driven away from the sheath fixing seat 516, thereby driving the proximal end (the outer end of the return section) of the actuating wire 230 away from the handle housing 511. Preferably, the inner end of the withdrawal rod 565 is configured as a flange structure, the outer end of the withdrawal rod 565 is fixedly connected to the withdrawal rod cap 566, and the cross-sectional size of the movable channel provided by the outer end of the sealing end cap 564 for the withdrawal rod 565 is smaller than the cross-sectional size of the flange structure of the withdrawal rod 565. When the withdrawal rod cap 566 is operated to pull away from the withdrawal rod 565 and move outward, the flange structure of the withdrawal rod 565 is limited by the outer end of the sealing end cap 564, that is, the pulling stops, that is, the withdrawal distance of the withdrawal rod 565 is limited, which can prevent the connection relationship between the actuating wire 230 and the distal end of the sheath tube 59 from being damaged by misoperation.

[0083] Further, refer to Fig. 10C The top of the sheath fixing seat 516 is provided with a Luer interface 555 connected to the inner cavity 517, and the Luer interface 555 is externally connected to the one-way Luer 519, for example, the one-way Luer 519 is directly bonded to the Luer interface 555, so as to realize the one-way exhaust seal of the sheath fixing seat 516 and the sheath 59.

[0084] In the longitudinal connection direction of the sheath tube fixing seat 516, a first set of sealing structures for sealing the actuating shaft 220 and the push-pull component is provided at the proximal end of the inner cavity 517 thereof. FIG. 10A to FIG. 10C, the first set of sealing structures is arranged at the connection between the distal end of the push slide rail 512 and the proximal end of the sheath fixing seat 516. The first set of sealing structures includes a silicone sealing sheet 541a, two first O-rings 541b, a second O-ring 541c, a first cover plate 551 and a second cover plate 552. The tops of the sheath fixing seat 516, the first cover plate 551 and the second cover plate 552 are basically flush, and the three are sealed and connected in the axial direction through the silicone sealing sheet 541a, the first O-ring 541b and the second O-ring 541c. The first set of sealing structures realizes the sealing of the entire cavity of the sheath fixing seat 516 in the axial direction, and also realizes the sealing of the actuating shaft 220 or the first reinforcing tube 223 (described later, in which the actuating shaft 220 extends) and the shaft length 537b. Furthermore, in order to ensure the effectiveness of the axial sealing, the length of the axial length portion 537b of the push seat is configured to be greater than or equal to the distance between the first stop position and the second stop position (the maximum axial stroke of the push-pull component). In particular, the first connecting portion 533 and the second connecting portion 534 are respectively arranged at the distal ends of the two push seats, and the proximal section of the actuating wire 230 is completely placed in the cavity of the sheath fixing seat 516, which can convert the sealing of the wire into the sealing of the axial length section of the push seat, thereby improving the sealing performance.

[0085] The proximal end of the sheath holder 516 is configured to have a recessed area 516a (see Fig. 10C ), the silicone seal sheet 541a can be located in the recessed area 516a, and the appearance of the silicone seal sheet 541a is configured to be substantially consistent with the transverse profile of the sheath fixing seat 516, and the first cover plate 551 presses the silicone seal sheet 541a from the proximal side and is connected to the proximal end of the sheath fixing seat 516. The first cover plate 551 includes two side channels 551b suitable for the push seat to pass through and a central channel 551a suitable for the actuating shaft 220 to pass through. The preferred central channel 551a is provided by an axially extending cylindrical body, which can be received by the transition cavity 517c and will not interfere with the axial movement of the two push seats. The proximal ends of the two side channels 551b are respectively provided with recessed steps 551c suitable for the first O-ring 541b to be located therein, and the proximal end of the central channel 551a is provided with a recessed step 551d suitable for the second O-ring 541c to be located therein. The second cover plate 552 presses the two first O-rings 541b and the second O-ring 541c from the proximal side and provides an extension channel for the push seat and the actuating shaft 220. Preferably, the first sealing assembly is connected together by tightening bolts 543, and is placed in the handle housing 511 after the first sealing assembly is fully assembled.

[0086] Further, in the transverse connection direction of the sheath fixing seat 516, a second set of sealing structures is provided for each actuating wire withdrawal assembly. Fig. 9CA silicone sealing gasket 542a is provided at the coupling of the withdrawal fixing seat 563 and the sheath fixing seat 516, and a third O-ring 542b is provided between the withdrawal rod 565 and the withdrawal fixing seat 563 in the inner cavity of the withdrawal fixing seat 563. The second set of sealing structures realizes the sealing of the entire cavity of the sheath fixing seat 516 in the transverse direction, and also realizes the sealing of the actuating wire.

[0087] The sheath tube fixing seat 516 with an inner cavity structure first provides a connection / fixing position for the sheath tube 59, and secondly provides a discharge interface for the gas in the sheath tube 59. In addition, it also provides an interface, a movable space or a accommodating space for the fixing / axial movement of the proximal end of the actuator wire itself, the axial movement of the push-pull component connected to the actuator wire, and the axial movement of the actuator shaft. On this basis, only the basic sealing O-ring and the sealing cover plate are set at the connection between the sheath tube fixing seat 516 and the push slide rail 512, and at the connection with the actuator wire withdrawal component, so as to achieve effective sealing of the small-diameter actuator shaft (or its outer reinforced tube) and the actuator wire, and at the same time, it is convenient to install and simple to operate, and the overall structure of the handle 51 is simplified.

[0088] refer to Fig. 6A and Fig. 10A The actuating shaft 220 in the handle 51 is sleeved with a first reinforcing tube 223, and a section located in the inner cavity 517 of the sheath fixing seat 516 is also sleeved with a second reinforcing tube 225, that is, the second reinforcing tube 225 is sleeved on the distal section of the first reinforcing tube 223, more specifically, the second reinforcing tube 225 is arranged in the inner cavity of the sheath fixing seat 516. The first reinforcing tube 223 can move axially in the second reinforcing tube 225, and the two reinforcing tubes simultaneously play a role in supporting and reinforcing the actuating shaft 220. Alternatively, the reinforcing tube may not be provided, and the strength of the section of the actuating shaft 220 located in the handle 51 may be adjusted to be greater than the strength of the other section of the actuating shaft extending in the sheath 59. Specifically, the material of the two sections of the reinforcing tubes may be medical stainless steel. The proximal end of the first reinforcing tube 223 is riveted, bonded or welded to the actuating shaft 220 at the proximal end of the handle 51, and the proximal end of the first reinforcing tube 223 and the actuating shaft 220 at the proximal end of the handle 51 are bonded or integrally injection-molded and fixed together in the hollow fine cavity 582 (described below) of the cylindrical body 524. The second reinforcing tube 225 is fixed in the cavity extending from the first cover plate 551 by bonding or integral injection molding.

[0089] The first reinforcing tube 223 is extended to the cylindrical body 524 and into the rotary handle 584, so that the first reinforcing tube can be easily sealed. Specifically, in the first sealing assembly, the second O-ring 541c seals the first reinforcing tube 223 to seal the actuating shaft 220. Since the diameter of the actuating shaft 220 is smaller than the diameter of the first reinforcing tube 223, and the actuating shaft 220 needs to move axially, the sealing size here is enlarged by the first reinforcing tube 223, so that a better sealing effect can be achieved.

[0090] refer to Figure 5A and Figure 5B The actuation shaft control mechanism 520 provided by the present invention generally includes a manipulation component, assembly or mechanism capable of longitudinally moving the actuation shaft 220, thereby enabling the clip 150 of the implant 100 to move between an open position and a closed position. Specifically, the actuation shaft control mechanism 520 includes a control knob 521, which is coupled to the actuation shaft 220 and can rotate relative to the handle housing 511, wherein the rotation of the control knob 521 causes the actuation shaft 220 to axially move relative to the handle housing 511 and the sheath 59.

[0091] Further, the control knob 521 is rotatably coupled to the handle housing 511, and the control knob 521 and the actuation shaft 220 are selectively coupled. When the control knob 521 is coupled to the actuation shaft 220, rotating the control knob 521 can cause the actuation shaft 220 to move axially relative to the handle housing 511 and the sheath 59. When the control knob 521 is uncoupled from the actuation shaft 220, the actuation shaft 220 can be operated alone, for example, the actuation shaft 220 can be manually pulled to continue to move toward the proximal end.

[0092] Further, the actuating shaft control mechanism 520 also includes an axial limiter 522 that can release the limit. In the process of controlling the opening and closing of the clip of the implant 100 by the actuating shaft 220 until the actuating shaft 220 is completely separated from the implant 100 after the implantation is completed, the axial limiter 522 provides axial limit for the actuating shaft 220 in the first position and the second position. Among them, the first position and the second position are arranged on the proximal side of the actuating shaft 220, the first position and the second position have an axial spacing, and the first position is located on the proximal side of the second position. When the axial limiter 522 provides axial limit to the actuating shaft 220 in the first position, the actuating shaft 220 can move axially between the distal position and the first proximal position under the rotation of the control knob 521. When the axial limiter 522 provides axial limit to the actuating shaft 220 in the second position, the position of the actuating shaft 220 is fixed at the second proximal position. Among them, when the actuating shaft 220 is located at the distal position, the clip 150 of the implant 100 is in a fully open state (the opening angle is maximum, 360°); when the actuating shaft 220 is located at the first proximal position, the clip 150 of the implant 100 is in a closed state; when the actuating shaft 220 is located at the second proximal position, the actuating shaft 220 and the implant 100 are in a disconnected state, and the distal end of the actuating shaft 220 is restored to a state where the implant can be reconnected.

[0093] When the implant 100 is manipulated by the actuating shaft 220, after the actuating shaft 220 reaches the first proximal position, the axial stopper 522 needs to be manipulated to release the limit of the actuating shaft 220 at the first position. When the axial stopper 522 releases the limit of the actuating shaft 220 at the first position, the actuating shaft 220 is decoupled from the control knob 521, and the actuating shaft 220 can be directly pulled to move axially, more specifically, to move axially proximally to the second proximal position.

[0094] In order to prevent the actuating shaft 220 from further moving toward the proximal end after reaching the second proximal position, a second position is set corresponding to the axial stopper 522 in the extending direction of the actuating shaft 220, so that the axial stopper 522 provides axial limitation to the actuating shaft 220 at the second position. In other words, when the actuating shaft 220 moves to the second proximal position, the axial stopper 522 provides axial limitation to the actuating shaft 220 at the second position, so that the actuating shaft 220 cannot continue to move toward the proximal end.

[0095] In other words, the axial stopper 522 can be selectively coupled to a first position or a second position located proximal to the actuating shaft 220. When the axial stopper 522 is coupled to the first position, the actuating shaft 220 can axially move between the distal position and the first proximal position under the rotation of the control knob 521. When the actuating shaft 220 is located at the first proximal position and the axial limit of the axial stopper 522 at the first position is released, the actuating shaft 220 can be separated from the rotation of the control knob 521 and continue to move axially toward the proximal end until the axial stopper 522 is coupled to the second position, so that the axial stopper 522 provides axial limit to the actuating shaft 220 at the second position. When the axial stopper 522 provides axial limit to the actuating shaft 220 at the second position, the actuating shaft 220 is located at the second proximal position.

[0096] Furthermore, the actuating shaft control mechanism 520 further includes a handle 584 whose rotation direction can be selectively limited, and the rotation of the handle 584 effectively rotates the actuating shaft 220 relative to the implant 100, thereby separating the implant 100 from the actuating shaft 220. Furthermore, a one-way rotation control mechanism is provided for the rotation of the handle 584, so that the actuating shaft 220 rotates in a single direction, which can prevent or inhibit the actuating shaft 220 from rotating in a tighter direction, thereby preventing the actuating shaft 220 from being locked in the connection with the implant 100 and unable to be separated.

[0097] refer to Figure 5A , Figure 5B , Fig. 10A and Fig. 10D The actuating shaft control mechanism 520 includes a control knob 521, a push screw 523 and an axially extending cylindrical body 524. The control knob 521 is connected to the proximal section of the handle housing 511 from the outside, the push screw 523 is connected to the control knob 521 and the cylindrical body 524 respectively, and the proximal end of the actuating shaft 220 is fixedly connected to the cylindrical body 524. The proximal end of the cylindrical body 524 constitutes the proximal end of the handle 51 and forms a rotary knob 584, and the distal end of the cylindrical body 524 extends axially into the hollow push screw 523. The actuating shaft 220 starts from the cylindrical body 524, and then extends through the push screw 523, the control knob 521, the push slide rail 512 and the sheath fixing seat 516 in sequence and enters the sheath 59. The proximal section of the handle housing 511 is configured to have a longitudinally extending inner cavity for providing a receiving space and a movable space for the push screw 523 during axial movement. The push screw 523 cannot rotate relative to the handle housing 511. Specifically, the inner cavity of the proximal section of the handle housing 511 is provided with an axially extending groove, and the distal end of the push screw 523 is provided with a convex tooth, and the groove teeth cooperate so that the push screw 523 can only move axially relative to the handle housing 511 but cannot rotate relative to the handle housing 511.

[0098] When the axial stopper 522 is coupled to the first position, the axial positions of the push screw 523 and the cylindrical body 524 are relatively fixed, and then the axial positions of the push screw 523 and the actuating shaft 220 are relatively fixed, so that the actuating shaft 220 moves with the axial movement of the push screw 523. Specifically, the control knob 521 is connected to the proximal section of the handle housing 511 from the outside and the proximal end of the control knob 521 is provided with an internal thread, and the push screw 523 is provided with an external thread that can match the internal thread of the proximal end of the control knob 521. The rotation of the control knob 521 advances or retracts the push screw 523 in the axial direction, so that the push screw 523 axially moves into or out of the inner cavity of the proximal section of the handle housing 511, thereby causing the actuating shaft 220 to move axially. That is, when the control knob 521 rotates about the axis of the handle 51, the rotation is converted into axial movement of the actuation shaft 220 and effectively axially advances or retracts the actuation shaft 220 to open or close the clip 150 of the implant (valve repair device).

[0099] refer to Fig. 10A and Fig. 10D The push screw 523 is constructed to include a small diameter section 523a and a large diameter section 523b; the small diameter section 523a provides a rotation coupling path for the control knob 521, and the rotation of the control knob 521 causes the push screw 523 to move axially, thereby causing the actuating shaft 220 to move axially relative to the handle housing 511 and the sheath 59. The large diameter section 523b provides an installation position for the axial limiter 522 and the one-way rotation control mechanism, and the proximal end of the cylindrical body 524 extends beyond the proximal end of the large diameter section 523b, and the proximal end of the cylindrical body 524 forms a radially enlarged rotary handle 584. Further, the outer wall of the small diameter section 523a is provided with a stroke indicator mark 523c along the axial direction, and the stroke indicator mark 523c reflects the opening angle of the distal implant 100 (the opening angle of the clip 150) under the axial movement of the actuating shaft 220. Generally, in the process of controlling the opening and closing of the clip of the implant by the actuating shaft 220, the actuating shaft 220 corresponding to the initial state and the end state is located at the first proximal position. For example, the actuating shaft 220 moves from the first proximal position to the distal end to gradually open the clip, and when the actuating shaft 220 moves to the distal position, the opening angle of the clip of the implant is the largest (360°); after capturing the leaflet, the actuating shaft 220 moves proximally back to the first proximal position, at which time the opening angle of the clip 150 is the smallest (engaged with the mating element 120). More specifically, refer to Fig. 10AThe cylindrical body 524 is provided with an axially extending hollow cavity 582, the actuating shaft 220 extends through the hollow cavity 582 and the proximal end of the actuating shaft 220 is fixed to the proximal end of the hollow cavity 582, and the reinforcing section or the first reinforcing tube 223 of the actuating shaft 220 extends from the proximal end of the hollow cavity 582 to the proximal end of the sheath tube 59. By providing the hollow cavity 582 in the cylindrical body 524, the connection length of the first reinforcing tube 233 and the proximal end of the actuating shaft 220 is increased, thereby increasing the bonding area between the two and strengthening the fixed connection strength of the two at the proximal end.

[0100] refer to Fig. 10A and Fig.11A , the first position 524a and the second position 524b when the axial stopper 522 provides the limit are both provided by the cylindrical body 524. When the axial stopper 522 provides the axial limit at the first position 524a or the second position 524b (refer to Fig. 11B and Fig.11D ), the cylindrical body 524 and the push screw 523 are relatively fixed in the axial direction. When the axial limiter 522 is released from the axial limit at the first position 524a or the second position 524b (refer to Fig. 11C and Fig.11E ), the cylindrical body 524 can move axially relative to the pushing screw 523. Specifically, the cylindrical body 524 can move axially by pulling or pushing the rotary handle 584.

[0101] refer to Figure 5A , Fig. 10A , FIG. 11A to FIG. 11EThe axial limiter 522 is a limit mechanism that can release the limit, and is arranged on the large diameter section 523b of the push screw. The axial limiter 522 includes a push member 528, a stopper 525 and a spring member 529. The stopper 525 includes an annular plate 525a and a first end 525b and a second end 525c extending from the annular plate 525a to two radially opposite sides. The first end 525b of the stopper 525 is connected to the push member 528, and the second end 525c of the stopper 525 is connected to the spring member 529. The spring member 529 is supported by the inner wall of the large diameter section 523b of the push screw. The cylindrical body 524 extends through the middle hole of the annular plate 525a, and the cylindrical body 524 is provided with a first engaging portion 571a corresponding to the first position 524a and a second engaging portion 571b corresponding to the second position 524b. Specifically, the first engaging portion 571a and the second engaging portion 571b are both configured as circumferentially extending grooves. The push member 528 is arranged at the top of the large diameter section 523b as the operating end of the axial limiter 522, and a part of the push member 528 is exposed above the large diameter section 523b. More specifically, the bottom of the large diameter section 523b is provided with a receiving groove 578, and the spring member 529 is seated in the receiving groove 578, and the receiving groove 578 provides support for the spring member 529. When the axial limiter 522 provides axial limit at the first position 524a or the second position 524b, the push member 528 is in a pop-up state, and the spring member 529 causes the annular plate 525a to engage with the first engaging portion 571a or the second engaging portion 571b to limit the axial movement of the cylindrical body 524. When the axial limiter 522 releases the axial limit at the first position 524a or the second position 524b (the axial limiter releases the coupling with the actuating shaft from the first position or the second position), the push member 528 is in a pressed state, the annular plate 525a moves toward one side of the spring member 529 to compress the spring member 529, and the annular plate 525a releases the engagement with the first engaging portion 571a or the second engaging portion 571b, thereby releasing the axial movement restriction on the cylindrical body 524; at this time, the cylindrical body 524 can be directly moved axially. For example, when the annular plate 525a is released from the first engagement portion 571a, the cylindrical body 524 is pulled toward the proximal end. Under the elastic force of the spring member 529, the inner wall of the annular plate 525a can contact the outer wall of the cylindrical body 524. When the cylindrical body 524 moves to align its second engagement portion 571b with the annular plate 525a, the annular plate 525a engages with the second engagement portion 571b under the elastic force of the elastic member 529, thereby realizing automatic axial limiting of the actuating shaft 220. More specifically, the first position 524a is located proximal to the second position 524b, and the distance between the first position 524a and the second position 524b defines the distance between the first proximal position and the second proximal position of the actuating shaft 220.

[0102] Preferably, the first engaging portion 571a is configured as a groove with a non-circular cross section. When the annular plate 525a is clamped to the first engaging portion 571a, the cylindrical body 524 cannot rotate, thereby the actuating shaft 220 cannot rotate. When the annular plate 525a is unclamped from the first engaging portion 571a, the cylindrical body 524 can rotate in a selectable direction.

[0103] When the control knob 521 is operated to place the actuating shaft 220 at the first proximal position, that is, when the stroke indicator mark 523c is aligned to the minimum scale, the axial stopper 522 can be operated to release the engagement between the annular plate 525a and the first engagement portion 571a, thereby releasing the coupling between the control knob 521 and the cylindrical body 524 (actuating shaft 220). Then, rotating the handle 584 in a first direction (e.g., counterclockwise) can disconnect the actuating shaft 220 from the implant 100. By setting a unidirectional rotation control mechanism to limit the rotation direction of the cylindrical body 524, it is possible to avoid the actuating shaft 220 from rotating in a second direction (e.g., clockwise) when the actuating shaft 220 is in a connected state with the implant 100 and entering the thread dead zone and being unable to separate.

[0104] refer to Figure 5A , Fig. 10A , FIG. 12A to FIG. 12C The one-way rotation control mechanism is specifically configured as a one-way clutch 526, which is arranged at a position on the large diameter section 523b different from the axial limiter 522. More specifically, the one-way clutch 526 and the axial limiter 522 are staggered in the axial direction, and the operating ends of the two are arranged oppositely in the radial direction. For example, the axial limiter 522 is arranged at the proximal side and upper part of the large diameter section 523b, and the one-way clutch 526 is arranged at the distal side and lower part of the large diameter section 523b. The one-way clutch 526 extends radially as a whole and is relatively fixed to the push screw 523 in the axial direction. The inner end of the one-way clutch 526 is configured to include asymmetric teeth, and the inner end can be releasably abutted against the side wall of the cylindrical body 524. A section of the cylindrical body 524 where the one-way clutch 526 abuts is configured as a spline, and the spline teeth of the abutting section are configured as a one-way ratchet, which can engage with the inner end of the one-way clutch 526. More specifically, the length of the spline of the section of the cylindrical body 524 with the one-way ratchet needs to be satisfied, and the distal end of the actuating shaft 220 can be screwed out of the threaded section of the distal end of the implant 100 (flap clip). When the inner end of the one-way clutch 526 is engaged with the cylindrical body 524, the cylindrical body 524 can rotate in a first direction (e.g., counterclockwise) to disengage the actuating shaft 220 from the implant 100, and inhibit the cylindrical body 524 from rotating in a second direction (e.g., clockwise). When the inner end of the one-way clutch 526 is disengaged from the cylindrical body 524, the cylindrical body 524 can rotate in the second direction to re-reuse the actuating shaft 220 to couple the implant.

[0105] Continue to refer Fig. 12A and Fig. 12B Specifically, the one-way clutch 526 includes a clutch knob 549, a clutch sleeve 546, a clutch shaft 527, and a clutch spring 576. The inner end of the clutch shaft 527 is configured to include asymmetric teeth, the clutch spring 576 is sleeved to the clutch shaft 527, one end of the clutch spring 576 abuts against the inner wall of the large diameter section 523b, and the other end of the clutch spring 576 abuts against the inner end of the clutch shaft 527. The clutch sleeve 546 and the clutch shaft 527 are relatively fixed in the axial direction of the clutch shaft 527, and the clutch sleeve 546 is rotatably connected to the outer end of the clutch shaft 527 around the axis of the clutch shaft 527. The clutch knob 549 is fixedly connected to the clutch sleeve 546 from the outside, and the outer periphery of the clutch knob 549 is provided with anti-slip features. The clutch knob 549 is configured as an operating end of the one-way clutch 526 . Operating the clutch knob 549 can cause the clutch sleeve 546 to move and rotate radially relative to the large diameter portion 523 b of the push screw 523 .

[0106] Further, refer to Fig. 12C The outer periphery of the clutch sleeve 546 is provided with a protrusion 547 such as a rib, and the peripheral side of the large diameter portion 523b of the push screw 523 is provided with a notch 548 capable of engaging with the protrusion 547. When the clutch sleeve 546 rotates and moves inwardly to make the protrusion 547 seated in the notch 548 outside the large diameter portion 523b, the side wall of the notch 548 restricts the rotation of the clutch sleeve 546, and the inner end of the clutch shaft 527 meshes with the columnar body 524 under the action of the clutch spring 576, so that the columnar body 524 can only rotate in one direction, thereby making the actuating shaft 220 only rotate in one direction. When the clutch sleeve 546 moves outward to make the protrusion 547 disengage from the slot 548 on the outside of the large diameter portion 523b, the clutch spring 576 is compressed, the inner end of the clutch shaft 527 disengages from the cylindrical body 524, and the clutch sleeve 546 can be rotated to make the clutch sleeve 546 abut against the non-slot position on the outer periphery of the large diameter portion 523b of the push screw.

[0107] The working method of the axial limiter 522 and the one-way clutch 526 is described below.

[0108] When the actuating shaft 220 and the implant 100 are kept in threaded connection, the axial stopper 522 provides axial stop at the first position 524a. The protrusion 547 on the clutch sleeve 546 is aligned with the notch 548 on the large diameter portion 523b of the push screw 523, and the protrusion 547 is seated in the notch 548. The side wall of the notch 548 limits the rotation of the clutch sleeve 546, and the inner end of the clutch shaft 527 is engaged with the cylindrical body 524, and the rotary handle 584 can only rotate in the first direction (counterclockwise).

[0109] The control knob 521 can be operated to advance or retreat the actuating shaft 220, thereby opening (the clip 150 is open) or closing (the clip 150 is closed) the implant 100. When the actuating shaft 220 moves proximally to the first proximal position after capturing the valve leaflet, the implant 100 is in a closed state, and the control knob 521 rotates relative to the push screw 523 to make the stroke of the actuating shaft moving proximally reach the limit, and the control knob 521 cannot move the actuating shaft 220 further proximally.

[0110] Further, pressing the push member 528 releases the axial limiter 522 from being limited at the first position 524a. Rotating the rotary handle 584 in a first direction (counterclockwise) releases the threaded connection between the actuating shaft 220 and the implant 100.

[0111] Further, the handle 584 is pulled toward the proximal end to drive the actuating shaft 220 to move axially. When the cylindrical body 524 moves toward the proximal end to the second position 524b aligned with the axial stopper 522, the actuating shaft 220 moves to the second proximal position, and the spring member 529 is reset to make the annular plate 545 automatically move up to the annular groove corresponding to the second position 524b, so that the axial stopper 522 resumes the axial limit of the cylindrical body 524.

[0112] Furthermore, the clutch knob 549 is pulled outward (downward) and rotated, so that the protrusion 547 on the clutch sleeve 546 leaves the notch 548 and is offset from the notch 548 in the rotation direction, and the engagement between the inner end of the clutch shaft 527 and the cylindrical body 524 is released. On this basis, the handle 584 is rotated in the second direction (clockwise) to connect the actuating shaft 220 to the implant for the second time.

[0113] The above are only several embodiments of the present disclosure. Those skilled in the art may make various changes or modifications to the embodiments of the present disclosure based on the contents disclosed in the application documents without departing from the spirit and scope of the present disclosure.

Claims

1. A sheath assembly for manipulating an implant, the sheath assembly comprising: Handle housing; a multi-lumen tube extending distally from the handle housing; an actuation shaft extending through the multi-lumen tubing, the actuation shaft being configured to be coupled to the implant; as well as An actuating shaft control mechanism, the actuating shaft control mechanism comprising: a control knob coupled to the actuation shaft, the control knob being rotatable relative to the handle housing, wherein rotation of the control knob causes the actuation shaft to move axially relative to the handle housing and the multi-lumen tubing; and a releasable axial stopper, the axial stopper being selectively coupled to a first position or a second position located proximal to the actuation shaft; Wherein, when the axial limiter is coupled to the first position, the actuating shaft can move axially between the distal position and the first proximal position under the rotation of the control knob; when the actuating shaft is located at the first proximal position and the axial limit of the axial limiter at the first position is released, the actuating shaft can be separated from the rotation of the control knob and continue to move axially toward the proximal end until the axial limiter is coupled to the second position; when the axial limiter is coupled to the second position, the axial limiter provides axial limit to the actuating shaft at the second position, and the actuating shaft is located at the second proximal position; Among them, the first position is located proximal to the second position; when the actuating shaft is located at the distal position, the opening angle of the implant is the largest; when the actuating shaft is at the first proximal position, the opening angle of the implant is the smallest; when the actuating shaft is at the second proximal position, the actuating shaft and the implant are in a disconnected state, and the distal end of the actuating shaft is restored to a state where it can be reconnected to the implant.

2. The sheath tube assembly according to claim 1, characterized in that: The actuating shaft control mechanism also includes a push screw, which is axially movably connected to the handle housing and is axially fixed relative to the axial limiter. The push screw is threadably coupled to the control knob, so that rotation of the control knob advances or retracts the push screw in the axial direction, thereby causing axial movement of the actuating shaft.

3. The sheath tube assembly according to claim 2, characterized in that: The actuating shaft control mechanism further comprises an axially extending cylindrical body, the proximal end of the actuating shaft is fixedly connected to the cylindrical body, the distal end of the cylindrical body extends axially into the pushing screw, and the cylindrical body provides the first position and the second position; When the axial limiter is coupled to the first position or the second position, the cylindrical body and the push screw are relatively fixed in the axial direction; when the axial limiter is uncoupled from the first position or the second position, the cylindrical body can move axially relative to the push screw.

4. The sheath tube assembly according to claim 3, characterized in that: The axial limiter is arranged at the proximal end of the pushing screw, and the proximal end of the pushing screw is provided with a receiving groove; The axial limiter is constructed to include a push piece, a stop piece and a spring piece, the stop piece includes an annular plate and a first end and a second end extending from the annular plate toward two radially opposite sides, the first end of the stop piece is connected to the push piece, the second end of the stop piece is connected to one end of the spring piece, and the other end of the spring piece is located in and abuts against the accommodating groove; The cylindrical body extends through the middle hole of the annular plate, and is provided with a first engagement groove corresponding to the first position and a second engagement groove corresponding to the second position. When the spring member causes the annular plate to engage with the first engagement groove or the second engagement groove, the push member is in a pop-up state, and the axial limiter is coupled to the first position or the second position. When the push member is in the pressed state, the spring member is compressed, the annular plate is released from the first engagement groove or the second engagement groove, and the axial limiter is released from the first position or the second position.

5. The sheath tube assembly according to claim 4, characterized in that: The cross section of the first engaging groove is configured as a non-circular structure.

6. The sheath tube assembly according to claim 5, characterized in that: The actuating shaft control mechanism further includes a one-way clutch radially extending into the push screw, the one-way clutch and the push screw are relatively fixed in the axial direction, the inner end of the one-way clutch is configured to include asymmetric teeth, and the inner end of the one-way clutch can be releasably abutted against the cylindrical body; A section of the cylindrical body that contacts the one-way clutch is configured as a spline, and the spline teeth of the contacting section are configured as one-way ratchets that can mesh with the inner end of the one-way clutch; When the inner end of the one-way clutch is engaged with the cylindrical body, the cylindrical body can rotate in a first direction to disengage the actuating shaft from the implant and inhibit the cylindrical body from rotating in a second direction; when the inner end of the one-way clutch is disengaged from the cylindrical body, the cylindrical body can rotate in a second direction to reconnect the actuating shaft to the implant; wherein the first direction is opposite to the second direction.

7. The sheath tube assembly according to claim 6, characterized in that: The one-way clutch comprises a clutch sleeve, a clutch shaft and a clutch spring, the inner end of the clutch shaft is configured to include the asymmetric teeth, the clutch spring is sleeved on the clutch shaft, one end of the clutch spring abuts against the inner wall of the push screw, the other end of the clutch spring abuts against the inner end of the clutch shaft, the clutch sleeve and the clutch shaft are relatively fixed in the axial direction of the clutch shaft, and the clutch sleeve is rotatably connected to the outer end of the clutch shaft around the axis of the clutch shaft; The outer periphery of the clutch sleeve is provided with a protrusion, and the outer periphery of the push screw is provided with a notch capable of receiving the protrusion; When the clutch sleeve rotates and moves inwardly so that the protrusion is seated in the notch of the push screw, the inner end of the clutch shaft engages with the cylindrical body under the action of the clutch spring, and the side wall of the notch limits the rotation of the clutch sleeve; when the clutch sleeve moves outwardly so that the protrusion is disengaged from the notch of the push screw, the clutch spring is compressed, the inner end of the clutch shaft disengages from the cylindrical body, and the clutch sleeve is rotated so that the clutch sleeve abuts against the non-notch portion of the outer periphery of the push screw.

8. The sheath tube assembly according to claim 7, characterized in that: The one-way clutch also includes a clutch knob, which is fixedly connected to the clutch sleeve from the outside, and an anti-slip feature is provided on the outer periphery of the clutch knob.

9. The sheath tube assembly according to claim 6, characterized in that: The push screw is configured to include a small diameter section and a large diameter section arranged in the axial direction; The small diameter section provides a rotational coupling path for the control knob, and rotation of the control knob causes the push screw to move axially, thereby causing the actuation shaft to move axially relative to the handle housing and the multi-lumen tube; The large diameter section provides an installation position for the axial limiter and the one-way clutch, and the proximal end of the cylindrical body extends beyond the proximal end of the large diameter section, and the proximal end of the cylindrical body forms a radially enlarged rotary handle.

10. The sheath tube assembly according to claim 9, characterized in that: The small diameter section is provided with a stroke indicating mark along the axial direction, and the stroke indicating mark is used to indicate the opening angle of the implant.

11. The sheath tube assembly according to claim 3, characterized in that: The cylindrical body is provided with an axially extending hollow cavity, the actuating shaft extends through the hollow cavity and the proximal end of the actuating shaft is fixed to the proximal end of the hollow cavity; A reinforcing tube is disposed outside the actuating shaft, the reinforcing tube is fixedly connected to the actuating shaft, and the reinforcing tube extends from the proximal end of the hollow cavity to the proximal end of the multi-cavity tube.

12. A delivery system for delivering an implant, characterized in that: The delivery system comprises: a first sheath assembly having a handle and a sheath extending in an axial direction from the handle, the sheath of the first sheath assembly having a distal end portion including a steerable section; and a second sheath assembly, wherein the second sheath assembly is the sheath assembly according to any one of claims 1 to 11, wherein the multi-lumen tube of the second sheath assembly coaxially extends through the sheath of the first sheath assembly; Among them, a relative fixing mechanism is provided between the handle of the second sheath assembly and the handle of the first sheath assembly, and the relative fixing mechanism extends distally from the handle shell of the second sheath assembly. The relative fixing mechanism is configured to keep the distance between the handle of the first sheath assembly and the handle of the second sheath assembly fixed.

13. The conveying system according to claim 12, characterized in that The distance between the handle of the first sheath assembly and the handle of the second sheath assembly is adjustable.

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